Hsp90 Inhibitor STA-9090 in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

NCT01270880 | Completed Phase 2 Results DMC

• 2 other identifiers: 2010-070NCI-2010-02328
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

Hsp90 inhibitor STA-9090 may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. This phase II trial is studying how well Hsp90 inhibitor STA-9090 works in treating patients with metastatic hormone-resistant prostate cancer previously treated with docetaxel-based chemotherapy

Conditions

Adenocarcinoma of the Prostate; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• PFS Proportion Achieved With STA-9090 in Men With CRPC Who Have Received Prior Docetaxel Based Therapy

  Our primary objective was to determine the 6-month PFS rate by using a binary (yes/no) endpoint of 6 months of PFS. Treatment success was defined as achievement of at least 6 months of PFS. Patients who did not complete 6 months of ganetespib therapy for any reason (including death from any cause) were considered treatment failures and were recorded as not achieving the primary endpoint.

  At 6 months

Secondary Outcomes (5)

• Percentage Change in PSA

  From baseline to 12 weeks

• Overall Safety and Tolerability of STA-9090

  Day 1, 8, and 15 of each course and at end of treatment

• OS in Metastatic CRPC Who Have Received Prior Docetaxel Therapy

  From first dose to death or the date last known alive

• Association of PFS With PSA

  At 6 months

• Potential Markers for Predicting Drug Response or Efficacy

  At baseline, day 1 of course 3, and end of treatment

Study Arms (1)

Treatment (enzyme inhibitor therapy)

EXPERIMENTAL

Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: Hsp90 inhibitor STA-9090; Other: laboratory biomarker analysis; Genetic: polymerase chain reaction; Other: enzyme-linked immunosorbent assay; Genetic: RNA analysis; Other: spectrophotometry; Genetic: reverse transcriptase-polymerase chain reaction; Genetic: gene expression analysis

Interventions

Hsp90 inhibitor STA-9090 DRUG

Given IV

Also known as: STA-9090

Treatment (enzyme inhibitor therapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (enzyme inhibitor therapy)

polymerase chain reaction GENETIC

Correlative studies

Also known as: PCR

Treatment (enzyme inhibitor therapy)

enzyme-linked immunosorbent assay OTHER

Correlative studies

Also known as: ELISA

Treatment (enzyme inhibitor therapy)

RNA analysis GENETIC

Correlative studies

Treatment (enzyme inhibitor therapy)

spectrophotometry OTHER

Correlative studies

Treatment (enzyme inhibitor therapy)

reverse transcriptase-polymerase chain reaction GENETIC

Correlative studies

Also known as: RT-PCR

Treatment (enzyme inhibitor therapy)

gene expression analysis GENETIC

Correlative studies

Treatment (enzyme inhibitor therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed diagnosis of prostate adenocarcinoma with metastasis and objective progression or rising PSA despite androgen deprivation therapy and antiandrogen withdrawal when applicable
• Progression after docetaxel based chemotherapy is needed as follows:
• a) If measurable disease present, then either rising PSA, increase in size of the lesion/s or both should be present
• b) Patients with rising PSA only as progression must demonstrate a rising trend with 2 successive elevations at minimum intervals of 1 week; a minimum PSA of 5 ng/ml, or new areas of bony metastases on bone scan are required for patients with no measurable disease; no minimum PSA requirement for patients with measurable disease
• Patients should have received at least one prior docetaxel based regimen for metastatic disease; no maximum prior therapy
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
• Life expectancy of at least 3 months
• Prior radiation therapy or chemotherapy completed at least 28 days prior to enrollment
• All patients must be documented to be castrate with a testosterone level =\< 0.5 ng/ml; luteinizing-hormone-releasing hormone (LHRH) agonist therapy must be continued, if required to maintain castrate levels of testosterone; patients must be off antiandrogens for a minimum of 4 weeks for flutamide and 6 weeks for bicalutamide or nilutamide
• Absolute neutrophil count \>= 1,500 cells/uL
• Platelets \>= 100,000/uL
• Hemoglobin \>= 9.0 g/dL
• Serum creatinine =\< 1.5 x upper limit of normal (ULN); Note: if serum creatinine is \> 1.5 x ULN, subject is eligible if the calculated creatinine clearance (CLcr) is \>= 50 mL/min
• Total bilirubin =\< 1.5 x ULN
• For patients without documented bone metastases or for patients with liver metastases: transaminases (aspartate aminotransferase \[AST\]/serum glutamic oxaloacetic transaminase \[SGOT\] and/or alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase \[SGPT\]) may be up to 2.5 x institutional ULN if alkaline phosphatase is =\< ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are =\< ULN

You may not qualify if:

• Major surgery within 4 weeks prior to first dose of STA-9090
• Poor venous access for study drug administration or would require a peripheral or central indwelling catheter for study drug administration; study drug administration via indwelling catheters is prohibited at this time
• Use of any chemotherapy or other standard systemic treatments for prostate cancer, including investigational agents within 2 weeks or 6 half- lives of the agent, whichever is shorter, prior to receiving STA-9090; there must be at least 2 weeks between the end of palliative radiation and the start of study drug and all radiation therapy (XRT)-associated toxicities resolved to Grade 1 or 0
• History of severe allergic or hypersensitivity reactions to excipients (e.g., Polyethylene glycol \[PEG\] 300 and Polysorbate 80 \[i.e. docetaxel\])
• Baseline QTc \> 450 msec or previous history of QT prolongation while taking other medications
• Ventricular ejection fraction (Ef) =\< 55% at baseline
• Any history of current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass surgery
• History of current uncontrolled dysrhythmias, or requirement for antiarrhythmic medications, or Grade 2 or greater left bundle branch block
• New York Heart Association class II/III/IV congestive heart failure with a history of dyspnea, orthopnea, or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers or diuretics
• Current or prior radiation therapy to the left hemithorax
• Treatment with chronic immunosuppressants (e.g. cyclosporine following transplantation)
• Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital

Baltimore, Maryland, 21231, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

University of Medicine nd Denistry of New Jersey

Piscataway, New Jersey, 08854, United States

Location

University of Wisconsin Cancer Center Riverview

Wisconsin Rapids, Wisconsin, 54494, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

STA 9090; Polymerase Chain Reaction; Enzyme-Linked Immunosorbent Assay; Spectrophotometry; Reverse Transcriptase Polymerase Chain Reaction; Gene Expression Profiling

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Immunoenzyme Techniques; Immunoassay; Immunologic Techniques; Immunosorbent Techniques; Immunohistochemistry; Molecular Probe Techniques; Photometry; Chemistry Techniques, Analytical; Spectrum Analysis

Limitations and Caveats

Small sample size.

Results Point of Contact

• Title: Elisabeth I. Heath, M.D.
• Organization: Barbara Ann Karmanos Cancer Institute

heathe@karmanos.org

313-576-8715

Study Officials

• Elisabeth Heath

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2011
• First Posted: January 5, 2011
• Study Start: January 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 18, 2018
• Results First Posted: April 14, 2015

Record last verified: 2018-02

Locations

US (4)